BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MULTIPLE SYS-URINE DRAINAGE-CLOSED

    K Number: K840284 · Decision Apr 13, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    205
    Applicant Total
    2
    Review Days
    86

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    Basic Information

    Device Name
    MULTIPLE SYS-URINE DRAINAGE-CLOSED
    K Number
    K840284
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Luth Corp.
    Date Received
    January 18, 1984
    Decision Date
    April 13, 1984
    Product Code
    KNX
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNX Collector, Urine, (And Accessories) For Indwelling Catheter

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    Other Clearances by Luth Corp.

    K Number Device Name
    K840283 MULTIPLE BAG, LEG